Unequal Trials in New Drug Approvals: CDSCO Seeks Feedback for Policy Reform
New Delhi: With an aim to address the existing disparity between the first applicant who conducts full-scale clinical and bioequivalence (BE) studies for a new drug and subsequent applicants who secure approval for the same product without undertaking similar trials, the Central Drugs Standard Control Organisation (CDSCO) has invited comments from stakeholders to help formulate a fair and balanced policy for new drug approvals in India.
All stakeholders have been requested to submit their comments and suggestions on the matter within 30 days of this notice by emailing dci@nic.in and snd@cdsco.nic.in
According to the New Drugs and Clinical Trials (NDCT) Rules, 2019, applicants seeking approval for a new drug already approved in another country are generally required to conduct local clinical trials in the Indian population, though provisions exist for waivers under certain conditions.
The recent circular noted that for approval of a new drug, many a time, the CDSCO receives applications from multiple applicants along with the protocol for the conduct of a clinical trial and bioequivalence study.
CDSCO after reviewing such applications in consultation with the SEC grant permission to conduct the Clinical trial and bioequivalence study with the new drug to multiple applicants.
In many such cases, it has been observed that only one applicant actively conducts the clinical trial and the bioequivalence study with the new drug and submits the reports to CDSCO for its approval.
Once the new drug is approved for the first applicant based on clinical trial and bioequivalence study data, the other applicants simultaneously submit the BE study report and obtain approval for the same new drug as a subsequent application.
Thus, once a new drug has been approved for the first time in India, subsequent applicants seeking approval for the same drug are not required to conduct clinical trials.
Approval for such subsequent applicants is granted based on chemical and pharmaceutical data and bioequivalence study data.
Therefore, the CDSCO noted that there is a lack of a level playing field between the first applicant who obtains approval of a new drug for the first time in the country based on clinical trial and bioequivalence study data and the subsequent applicants who obtain approval of the same new drug based on bioequivalence study data for whom the cost of regulatory compliance is much lesser, as they are not required to conduct the clinical trial.
To address this discrepancy and promote fair competition while encouraging the development of new drugs in India, CDSCO has decided to deliberate the issue in consultation with stakeholders and relevant departments before taking an appropriate policy decision.
In line with the above, the circular stated, "This notice is intended to initiate discussion among the stakeholders. All the stakeholders are requested to provide their comments/suggestions on the subject at dci@nic.in and snd@cdsco.nic.in. This window of opportunity will close within 30 days."
To view the official notice, click the link below:
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